QA Associate Scientist - Evaric Pharmaceuticals, Inc. - 155 Commerce Drive, Happauge, NY 11788
(2022-07)
All types of components/materials are sampled, inspected, and tested (where applicable) for the purpose of determining compliance with established specifications.
- Monitor and ensure all phases of drug packaging comply with established specifications
- Receive, inspect, release, and control labels and Outsets
- Ensure quality compliance before, during, and after each packaging run
- Review all requirements from QA scientist and engineering records (temperature and humidity data calibration and PM records)
- Review online batch records in terms of completeness of signatures, entries, and actual reconciliation/yields before initiation of next processing step
- Verify functionality of all equipment and associated controls during the batch run
- Inspect packaging line during packing operation
QA Inspector II - Amneal Pharmaceuticals of NY, LLC - 50 Horseblock Road, Brookhaven, New York 11719
(2016-09 - 2022-07)
Quality Control Manager - Hallmark Pharmaceuticals Ltd. - B-63, BSCIC VA, Tongi Gazipur, Bangladesh
(2012-05 - 2013-09)
Implementation of Company Quality policy and ensuring compliance with quality standards.
- Approve or reject starting materials, packaging materials, and intermediate, bulk, finished products and per-purchase raw material
- Prepare and update all documentation related with testing, sampling instructions, specifications, test methods and validation
- Ensure that the appropriate validations, including those of analytical procedures and calibrations of control equipment and process validation are done
- Ensure that all necessary tests are carried out as mentioned in Product Master File
- Check the maintenance of the QA/QC equipment and sanitation
- Ensure WHO cGMP and ISO guidelines are followed
- Coordinate with Commercial Department for vendor selection
- Coordinate with Product Management and Regulatory Affairs for preparing of technical data, annexure and other document for Drug Administration
- Ensure that all documents and records are preserved correctly
- Monitor and control environment of plant area
- Directly monitor and control all the in-process tests/checks and instruct production for corrective measures if required
- Arrange adequate stocks of reagents, glassware and consumables are available
- Ensure that the required initial and continuing training of quality assurance personnel is carried out and adapted accordingly to need
Quality Control In-charge - NAVANA Health Care Limited - Rupshi, Rupgonj, Narayangonj, Bangladesh
(2008-07 - 2012-05)
Management of quality control operations and pharmaceutical testing procedures.
- Approve or reject starting materials, packaging materials, and intermediate, bulk, finished products and pre-purchase raw material
- Prepare and update all documentation related with testing, sampling instructions, specifications, test methods and validation
- Ensure that the appropriate validations, including those of analytical procedures and calibrations of control equipment and process validation are done
- Ensure that all necessary tests are carried out as mentioned in Product Master File
- Check the maintenance of the QA equipment and sanitation
- Ensure WHO cGMP and ISO guidelines are followed
- Coordinate with Commercial Department for vendor selection
- Coordinate with Product Management and Regulatory Affairs for preparing of technical data, annexure and other document for Drug Administration
- Ensure that all documents and records are preserved correctly
- Monitor and control environment of plant area
- Directly monitor and control all the in-process tests/checks and instruct production for corrective measures if required
- Arrange adequate stocks of reagents, glass wares and consumables are available
- Ensure that the required initial and continuing training of quality assurance personnel is carried out and adapted accordingly to need
- Determine complex chemical conversions including Radio-isotopic characteristics in medicines conducting programs of data collection and analysis to identify and quantify toxic-ants
- Develop and conduct new methods of analysis to ensure quality of materials
Senior Quality Control Officer - AVANA Pharmaceuticals Limited - Rupshi, Rupgonj, Narayanganj, Bangladesh
(2007-07 - 2008-06)
Quality Control Officer - AVANA Pharmaceuticals Limited - Rupshi, Rupgonj, Narayanganj, Bangladesh
(2003-12 - 2007-07)
Assistant Control Officer - AVANA Pharmaceuticals Limited - Rupshi, Rupgonj, Narayanganj, Bangladesh
(2001-04 - 2003-12)
Perform analysis testing and quality control operations in pharmaceutical manufacturing.
- Perform analysis testing of raw materials, bulk materials, and intermediates product
- Operate a variety of instruments in the QA Laboratory such as HPLC, IR, UVPC, ATOMIC Absorption, Karl Fischer, Dissolution Apparatus, and Friability Test Apparatus, etc.
- Document preparation and report writing
- Prepare reagents and proper labeling; conduct various validation works
- Conduct routine microbiological tests
- Perform and monitor calibration of QA equipment
- Direct Quality control procedures and manage the chemical technicians and technologists
- Develop and conduct new methods of analysis to ensure quality of materials
- Process and devise new technical applications of chemicals and compounds
- Determine complex chemical conversions, including Radio-isotopic characteristics in medicines, conducting programs of data collection and analysis to identify and quantify toxicants
